Huang, C.J., Hou, M.F., Kan, J.Y., Juan, C.H., Yuan, S.S., Luo, K. H., . . . Hu, S.C. (2015). Prophylactic treatment with adlay bran extract reduces the risk of severe acute radiation dermatitis: A prospective, randomized, double-blind study. Evidence-Based Complementary and Alternative Medicine, 2015, 312072.

To evaluate the efficacy of oral treatment with adlay bran extract to prevent severe radiodermatitis

Adlay is an annual cereal crop that has been used in Chinese medicine. Patients were randomly assigned to receive either capsules containing adlay bran extract or placebo (olive oil) twice daily. The dosage was two capsules 500 mg each taken twice daily from the first day to the last day of radiotherapy. Skin assessment was conducted at baseline and at the end of treatment, at 5–6 weeks. Patients were asked not to take anti-inflammatory medications or apply topical agents during the study period. Compliance to study medication was assessed at every follow-up visit.

• N = 110
• MEAN AGE = 51.6 years 
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer. The radiation therapy dose was 50–50.4 Gy administered in 1.8–2 Gy fractions five days per week. Those who had received breast-conserving surgery (BCS) were given an additional boost dose.
• OTHER KEY SAMPLE CHARACTERISTICS: Of the participants, 87% had received BCS. The mean body mass index was 22.6.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Taiwan

PHASE OF CARE: Active antitumor treatment

• Placebo-controlled, double-blind, randomized, controlled trial

• Radiation Therapy Oncology Group (RTOG) criteria for skin grading

In the adlay bran group, 5.5% had grade 0, 49.3% had grade 1, 34.2% had grade 2, and 11% had grade 3 radiodermatitis at the end of treatment. In the placebo group, 0% had grade 0, 24.3% had grade 1, 67.6% had grade 2, and 8.1% had grade 3 skin reaction. No patients developed grade 4 dermatitis. The overall lower severity of radiodermatitis in the adlay bran group was significant (p = 0.006). The majority did not have any adverse effects, and no serious adverse reactions were seen. Regression showed that higher body mass index and use of the adlay bran intervention were predictive of radiation dermatitis severity.

Patients receiving oral adlay bran extract had overall lower severity of skin reaction from radiation therapy.

• Unintended interventions or applicable interventions not described that would influence results
• Results of compliance assessment were not reported.

The findings suggest that prophylactic oral adlay bran extract may have a protective effect to reduce the severity of radiation dermatitis. This substance has been used in traditional Chinese medicine for centuries and is believed to have anti-inflammatory and antioxidant properties. Adlay bran may have potential for the prevention of severe radiodermatitis. Further studies are needed to determine the optimal dosage and duration of administration.